Drug History: REMERON

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

Browse by Letter: A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9

Label and Approval History

Drug Name:	REMERON
FDA Application No:	(NDA) 020415
Active Ingredient(s):	MIRTAZAPINE
Company:	ORGANON USA INC

Label History

View the label approved on July 31, 2007 for REMERON, (NDA) 020415

To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.

Approval History

Action Date	Supplement Number	Approval Type	Letters, Reviews, Labels, Patient Package Insert
7/30/2007	019	Labeling Revision	Letter Label
1/12/2005	018	Labeling Revision	Letter Label
6/1/2004	016	Labeling Revision	Letter
9/30/2002	015	Labeling Revision	Letter
11/20/2001	014	Manufacturing Change or Addition
1/26/2001	010	Manufacturing Change or Addition
4/9/2002	009	Efficacy Supplement with Clinical Data to Support	Letter
7/19/2000	008	Control Supplement
2/28/2000	007	Labeling Revision
8/30/2000	006	Labeling Revision
5/11/1999	005	Manufacturing Change or Addition
4/9/1998	004	Manufacturing Change or Addition
3/17/1997	003	Control Supplement	Review
11/7/1996	002	Control Supplement
11/4/1996	001	Control Supplement
6/14/1996	000	Approval	Other Important Information from FDA

Therapeutic Equivalents